PMA P970003S078

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S078
Product code: LYJ
Decision date: 2007-04-12
Classification: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: APPROVAL FOR THE ADDITION OF DETAILED INFORMATION CONTAINED IN THE APPROVED TEST TO THE FIGURES PROVIDED IN THE LABELING TO PROVIDE FURTHER CLARIFICATION CONCERNING THE PROPER LEAD IMPLANT TECHNIQUE. ADDITIONALLY, FURTHER DETAILS WERE PROVIDED TO STRESS THE IMPORTANCE OF PROPER STRAIN RELIEF PLACEMENT (I.E. PROPER TIE-DOWN LOCATION AND STRAIN RELIEF BEND).

Current openFDA PMA Record#

Device: VNS THERAPY SYSTEM
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S078
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2007-04-12
Decision code: APPR
Date received: 2007-03-27
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF DETAILED INFORMATION CONTAINED IN THE APPROVED TEST TO THE FIGURES PROVIDED IN THE LABELING TO PROVIDE FURTHER CLARIFICATION CONCERNING THE PROPER LEAD IMPLANT TECHNIQUE. ADDITIONALLY, FURTHER DETAILS WERE PROVIDED TO STRESS THE IMPORTANCE OF PROPER STRAIN RELIEF PLACEMENT (I.E. PROPER TIE-DOWN LOCATION AND STRAIN RELIEF BEND).